The following data is part of a premarket notification filed by Ace Medical Co. with the FDA for 6.5mm Solid Cancellous Bone Screw.
| Device ID | K954485 |
| 510k Number | K954485 |
| Device Name: | 6.5MM SOLID CANCELLOUS BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | ACE MEDICAL CO. 2260 EAST EL SEGUNDO BLVD. Los Angeles, CA 90245 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen ACE MEDICAL CO. 2260 EAST EL SEGUNDO BLVD. Los Angeles, CA 90245 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-27 |
| Decision Date | 1995-10-31 |